Malaria Microscopy Certification
“So, Bill – who reads the malaria smears in your lab?”
“Oh, most of us aren’t any good at it - we give them all to Joe. He’s our expert.”
Joe’s an expert… Says who?
Fact: There is no recognized certification program for malaria microscopy.
Fact: There is no standardized training program for malaria microscopists.
Fact: The promise of accurate, sensitive automated diagnostic systems using PCR or other advanced techniques has yet to be realized, much less FDA approved.
Question: Have any viable drug or vaccine candidates been abandoned due to false positives ?
Question: Has unnecessary treatment due to misdiagnosis contributed to drug resistance ?
So what are we going to do about it?
Prepared by Hydas World Health (HWH)
December, 2005
Hydas World Health is a US non-profit (501(c) 3) entity incorporated in March of 2005. While the recent establishment of this company precludes a long list of accomplishments, it’s purpose and reason for coming into existence is clear.
Ever since the discovery of the mosquito transmission of malaria and of its causal agent, the Plasmodium parasite, light microscopy of blood smears has been the principal means of confirming the symptomatic diagnosis of the disease and the only way to quantify parasitemia in infected blood. Despite the recent development of biochemical diagnostic methods of great promise, light microscopy remains the “gold standard” against which all other techniques must be judged. Yet for all its importance, light microscopy has a very significant Achilles heel. It relies completely, and too often fatally, on the skill of the microscopist charged with examining the slide. The flaw of complete reliance on the proficiency of the microscopist is often compounded by poor slide preparation or the use of inadequate equipment. But the fact remains that it is on the shoulders of the individual looking into the eyepiece that accurate diagnosis depends. Both in the clinical setting and in clinical trials of new drugs and vaccines, the skill of the technician is absolutely crucial.
Throughout the world there are many training programs that attempt to develop microscopists capable of meeting the challenge of accurately diagnosing malaria as well as other parasitic diseases of the blood. At universities or within Ministries of Health, technicians are trained and periodically tested on their diagnostic skills. But these programs are of widely varying quality and despite the importance of malaria as one of the greatest of threats to human health, there is no way to accurately judge the quality of these programs, nor to compare them with one another.
Recognizing this problem, the National Institutes of Health Malaria Research and Reference Reagent Resource Center (MR4) challenged Hydas, Inc., to demonstrate the feasibility of producing large numbers of high quality blood smear slides of known plasmodial composition, as the first and necessary step toward the development of a program that would address the issue of quality control and quality assurance in the diagnosis of malaria by light microscopy. Hydas successfully completed this proof-of-concept study in the fall of 2004. The sets of slides, which contain negative as well as mixed infection slides, and both P. falciparum and P. vivax at widely varying densities, are now accessible to authorized users of MR4 to utilize as they see fit.
Though the availability of appropriate training materials such as the Hydas slides is a necessary precondition, it is not by itself sufficient to address the overall problem of accurate diagnosis of malaria by light microscopy of blood smears – there must be a plan to use the slides as part of an integrated training and testing approach. It is to meet this challenge that we now propose to prepare more such slides and to use them as the basis for the development of a complete program of training, testing, and, most critically, certification, in diagnosis of malaria by light microscopy. The proposed slide sets would expand upon the southeast-Asia centered sets provided in the pilot study, including specimens from Latin America and Africa. They would be used to design a program of training and education that would be tested on groups of students, refined, and tested again until its effectiveness is demonstrated. The resulting assemblages of materials – slides, training regimens, and examinations – would then be packaged into a complete program of Certification in Light Microscopy for Malaria Diagnosis. This program should be adopted worldwide, resulting in an internationally recognized standard which would finally address this issue which has plagued malaria diagnosis for well over a century.